Kornimate/medical-research-clean huggingface dataset:
trial of thalidomide, a- interferon +/- octreotide in patients with unresectable hepatocellular carcinoma

Conditions: Liver; Cancer

Summary: primary aim determine the response rate and time to progression of the combination of thalidomide, interferon, and octreotide in patients with unresectable hepatocellular carcinoma (cancer of the liver that can't be treated surgically). secondary aims 1. determine the toxicity of this combination in this population. 2. determine the survival of this patient cohort treated with the combination. 3. determine the percent of patients with hepatocellular carcinoma who have a positive octreotide scan.

the purpose of this study is to determine the response rate and time to progression of the combination of thalidomide, alfa interferon, and octreotide (sandostatin lar) in patients with unresectable hepatocellular carcinoma. if patients are eligible for and agree to take part in the study, they will be assigned to one of two treatment arms depending on ssr status. if ssr status is positive or unknown, patients will receive oral doses of thalidomide starting at 200mg a day and increasing to 800mg at increments of 200 per week depending on tolerance. they will also receive injections three times a week of alpha interferon and monthly injections of octreotide (sandostatin lar) 30 mg into their buttocks muscle.. if the patient ssr status is negative, patients will not be given subcutaneous injections of octreotide (sandostatin lar) but will receive the thalidomide and alfa interferon only.

Eligibility criteria:
inclusion criteria: 1. histologically proven diagnosis of hepatocellular or radiographic evidence of a hepatic lesion consistent with hepatoma and an alpha feto protein \>500 ng/ ml 2. the tumor is unresectable 3. performance status of \< 2.0 4. \> 18 years of age 5. informed consent to be signed by patient 6. no previous treatment with thalidomide, alpha interferon, or octreotide 7. the patient may have received previous chemotherapy either systemically or via the intra hepatic artery. 8. the patient may have had previous surgery or regional therapy such as intra tumoral injection of alcohol, cryosurgery, or radiofrequency ablation. 9. the patient must have measurable disease. 10. if female, the patient must have a negative pregnancy test and agree not to fall pregnant during this therapy. 11. bilirubin \ 1.5, platelet\>75k 12. patients may not have symptomatic cholelithiasis. exclusion criteria:

Keywords: phase ii hepatocellular carcinoma
assessment of tear film thickness by optical coherence tomography in healthy subjects and subjects with dry eye disease

Conditions: Dry Eye Syndrome

Summary: dry eye syndrome (des) is a highly prevalent ocular condition with severe consequences for the patients reaching from ocular discomfort in its simplest form up to visual impairment and corneal ulceration in severe cases. data from epidemiological studies indicate that des is a common disease, especially in the elderly population, affecting up to 20% of adults aged 45 years or older. topical lubricants are a mainstay of therapy, but data on its effect on tear film thickness and the corneal residence time are lacking. recently, a new objective method for assessment of tear film thickness by optical coherence tomography has been developed. the present study aims to investigate the corneal residence time of an established topical lubricant compared to placebo in patients with des and healthy controls.


Eligibility criteria:
inclusion criteria: inclusion criteria for healthy subjects: * men and women aged over 18 years * normal findings in the medical history unless the investigator considers an abnormality to be clinically irrelevant * normal ophthalmic findings, ametropia \< 6 dpt * schirmer i test \> 10 mm and but \> 10 sec inclusion criteria for patients with dry eye syndrome: * men and women aged over 18 years * normal findings in the medical history unless the investigator considers an abnormality to be clinically irrelevant except des * normal ophthalmic findings, ametropia \< 6 dpt * history of dry eye syndrome for at least 3 months * tear break up time (but) \< 10 seconds or schirmer i test \< 7 mm * at least 2 symptoms of dry eye syndrome (foreign body sensation, burning, photophobia, blurred vision, pain, itching) * normal ophthalmic findings except dry eye syndrome exclusion criteria: * regular use of medication (except contraceptives), abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study * treatment in the previous 3 weeks with any drug * symptoms of a clinically relevant illness in the 3 weeks before the first study day * ametropia \>= 6 dpt * pregnancy * difference of more than 3 mm in schirmer i test or difference of \> 3 sec in but between the two eyes * known medical history of allergy, hypersensitivity or poor tolerance to any components of the medication or medical product used in the study

Keywords: topical lubricants tear film thickness break up time ocular surface disease index schirmer i test
exercise-based telerehabilitation program for police officers and firefighters with chronic non-specific low back pain

Conditions: Chronic Low-back Pain; Telerehabilitation

Summary: the aim of this clinical trial is to develop and test the effectiveness of a smartphone app-based self-management program based on exercise and pain education for police officers and firefighters with chronic low back pain.

low back pain is the leading cause of year lived with disability worldwide. workers exposed to physically demanding activities and inappropriate postures, such as those performed by police officers and firefighters, are highly affected by chronic low back pain. smartphone app-based self-managed interventions have been shown to be an alternative for chronic non-specific low back pain treatment. however, there is still little research on the development and testing of remotely-delivered programs for the management of chronic low back pain, especially in police and fire professionals. the aim of this clinical trial is to develop and test the effectiveness of a smartphone app-based self-management program based on exercise and pain education for police officers and firefighters with chronic low back pain.

Eligibility criteria:
inclusion criteria: * aged between 18 and 60 years * chronic low back pain (defined as pain lasting more than 12 weeks) * chronic low back pain of at least 3 points in a 0 to 10 pain numerical rating scale * own a smartphone with internet access and email account * police officer (federal, federal highway, civil or military) or military firefighter working in the state of rio grande do sul exclusion criteria: * present neurological symptoms (nerve root compromise, or sensation deficits) * present serious spinal diseases (e.g., fracture, tumor, inflammatory, autoimmune, and infectious diseases) * present serious cardiovascular and metabolic diseases (e.g., coronary heart disease, cardiac insufficiency, decompensated diabetes) * recent spine surgery (over the last 12 months) or scheduled to undergo surgery in the next six months, or pregnancy * history of physical therapy treatment for low back pain or physical exercise (strength training for core muscles, pilates, yoga) current or within the last 3 months * retired * if have any contraindication to exercise: we will perform a pre-screening for physical activity participation at baseline using the physical activity readiness questionnaire (par-q) portuguese version to rule out any contraindication to participate in physical activity

Keywords: low back pain telerehabilitation
improving treatment for children with intellectual and developmental disabilities and problem behavior in schools

Conditions: Problem Behavior; Intellectual Disability; Developmental Disorder

Summary: children with intellectual and developmental disabilities (idds) often engage in problem behavior, and functional communication training (fct) is a commonly used treatment for problem behavior in clinical settings. during fct, children learn prosocial ways to request functional reinforcers (e.g., "their way") instead of using problem behavior. for example, a child who engages in self-injury to escape math instruction may be taught to exchange a break picture card to receive a brief break from the math task as an alternative to self-injury. while the efficacy of fct is well established, less is known about its effects in school settings when procedures are necessarily adapted for feasibility. the purpose of this investigation is to develop and evaluate methods for implementing fct for children with idds in school settings. the investigators will use single case experimental design, in which each participant will serve as their own control, to address the research questions. first, the investigators will evaluate the effects of providing higher quality, longer duration reinforcement for appropriate requests relative to problem behavior (e.g., 1-minute break with a preferred activity versus 20-s break alone) during fct compared to providing equal reinforcement for appropriate requests and problem behavior. next, the investigators will develop a treatment extension to teach children to complete academic work to gain access to their way. the investigators will use visual cues, such as a green and red index card to teach children when it is time to work and when they may access their way. the investigators will evaluate the effects of the treatment extension on academic work completion, appropriate requests, and problem behavior. finally, the investigators will examine how visual cues influence children's behavior when educators implement intervention across different academic activities. the investigators will measure the extent to which educators implement programmed intervention procedures to inform treatment feasibility.


Eligibility criteria:
inclusion criteria: child eligibility criteria * preschool or elementary school students between 3-11 years old * has an intellectual or developmental disability * has a functional behavior assessment and behavior intervention plan or has been identified as needing a functional behavior assessment * exhibits problem behavior that occurs at least daily adult eligibility criteria * educator who provides direct services to the child participant exclusion criteria: child exclusion criteria * excessive absences from school * problem behavior occurs less frequently than daily

Keywords: functional communication training problem behavior alternatives to extinction
effect of epidural anesthesia on pancreatic perfusion and clinical outcome in patients with severe acute pancreatitis

Conditions: Severe Acute Pancreatitis

Summary: the aim of the study is to evaluate the safety, the potential beneficial effect of epidural anesthesia on pancreatic perfusion and clinical outcome of patients with severe acute pancreatitis.

high mortality in severe acute pancreatitis (ap) is linked to necrosis of the gland. animal studies showed that epidural anesthesia (ea) restores pancreatic microcirculation and decreases the severity of ap. the aim of the study is to evaluate the safety of ea, its effect on pancreatic perfusion and clinical outcome of patients with ap.

Eligibility criteria:
inclusion criteria: * acute pancreatitis with ranson criteria over 2, and/or crp over 100, and or pancreatic necrosis on ct scan exclusion criteria: * coagulation disorders * skin infection of the vertebral region

Keywords: epidural anesthesia pancreatic perfusion pancreatic necrosectomy
effect of covid-19 pandemic on vaccination compliance

Conditions: Vaccine Refusal

Summary: 1- evaluate the impact of the covid-19 pandemic on pediatric vaccinations compliance among children attending to assiut university children hospital ,assess the general health profile of studied children.

corona virus disease (covid-19) is a disease caused by a new corona virus called severe acute respiratory syndrome corona virus 2 (sars-cov-2). on march 11, the who director-general declared covid-19 a pandemic1. the first outbreak occurred in wuhan, china. 2,3 covid-19 pandemic has severely affected global health services.4 it is important not to overlook the value of some public health preventive interventions which cannot be postponed, such as vaccinations.5 as reported by who, the disruption of immunization services, even for brief periods, will result in increased numbers of susceptible individuals, raising the risks of an upsurge in outbreak-prone vpds.6 the reduction of vaccination coverage could cause an increase in morbidity and mortality among children. consequently, a greater burden could be placed on health systems. examples from previous large epidemics (e.g. diphtheria in the former soviet union in 1990-1996 and in venezuela in 2017-2018) show that, when vaccination coverage falls or vaccinations are disrupted, cases of infectious diseases that have disappeared can quickly re-emerge.7-8 egypt declared a national state of emergency to control covid-19 pandemic and implemented a stay-at-home order. such strategies might result in decreased accessibility to routine immunization services, leaving children at risk for vaccine-preventable diseases and their complications.9 great efforts are needed for rapid catch-up of children not up-to-date with routine vaccines. parental concerns about potentially exposing their children to covid-19 during vaccination visits might contribute to incompalince.10 reminding parents of the vital need to protect their children against serious vaccine-preventable diseases is critical.

Eligibility criteria:
inclusion criteria: * children from 12 to 24 months who admitted in assiut university children hospital or attending the outpatient clinics exclusion criteria: * : immunodeficiency (e.g chemotherapy, long term immunosuppressive therapy, hematologic tumor).

Keywords: covid19
a drug interaction study of boceprevir in combination with amlodipine or diltiazem in healthy volunteers

Conditions: Hepatitis C; Hypertension

Summary: the purpose of this study is to evaluate the pharmacokinetic interactions between the hepatitis c ns3 protease inhibitor boceprevir and the calcium channel blockers amlodipine and diltiazem in healthy volunteers.


Eligibility criteria:
inclusion criteria: 1. able and willing to sign informed consent prior to any study-related activities. 2. male or female subjects between 18 and 65 years of age inclusive. 3. healthy, i.e. not suffering from a relevant acute or chronic illness. 4. body mass index (bmi) of 17.5 to 31 kg/m2; and a total body weight \> 50 kg (110 lbs). 5. acceptable medical history, physical examination, and 12-lead ecg at screening. 6. acceptable laboratory values that indicate adequate baseline organ function at screening visit. 7. willing to stop using any herbal or natural health products for 2 weeks prior to and during the study including: grapefruit, grapefruit juice, st. john's wort. 8. willingness to abstain from alcohol use for 3 days prior to and during the study. 9. female subject is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or is of childbearing potential and practicing one of the following methods of birth control: * condoms, sponge, foams, jellies, diaphragm or intrauterine device (iud) * a vasectomized partner * total abstinence from sexual intercourse exclusion criteria: 1. have serological evidence of exposure to hiv or hcv. 2. known allergies to any of the study medications. 3. female subjects of childbearing potential who: * has a positive urine pregnancy test at screening. * is not willing to use a reliable method of barrier contraception during the study. * using only oral contraceptive as a birth control method. * is breastfeeding. 4. inability to adhere to protocol. 5. use of any medications (2 weeks prior to or during the study) other than occasional use of acetaminophen. 6. female subjects using contraceptives that contain drospirenone. 7. subjects that are currently smoking. 8. subjects with hypertension or heart disease requiring medical treatment. 9. any condition possibly affecting drug absorption (e.g., gastro intestinal disorder). 10. patients may be excluded from the study for other reasons, at the investigator's discretion.

Keywords: hcv pharmacokinetics boceprevir hypertension amlodipine diltiazem
magnesium sulfate to prevent hospitalisation of acute exacerbations of chronic obstructive pulmonary disease

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: the purpose of this study is to assess whether administration of a bolus dose of mgso4 (magnesium sulfate) plus standard therapy is superior to standard therapy alone for the management of acute exacerbations of chronic pulmonary obstructive disease (aecopd) in the emergency department. the investigators hypothesize that mgso4 causes faster recovery of the bronchospasm, and a reduction of the dead space, translating to the following clinical outcomes : less hospitalisation, lower length of stay (los), better composite outcome of hospitalisation + los + readmission for aecopd.

patients presenting to the participant emergency departments (ed) with a diagnosis of aecopd and who receive at least one dose of albuterol, will be randomized to receive either placebo or one dose of mgso4 2g iv. security and efficacy outcomes will be measured.

Eligibility criteria:
inclusion criteria: * current or previous smoking for at least 10 pack-years * confirmed copd : 1. reported by the patient if already diagnosed in the past by a pulmonary disease specialist or on the basis of respiratory function tests; or 2. new diagnosis in the ed, with confirmatory pulmonary tests showing forced expiratory volume (fev1) / forced vital capacity (fvc) ratio \< 70% and fev1\< 80% * patient requires at least one dose of albuterol (salbutamol). exclusion criteria: * dialysis patients * severe kidney disease, known or suspected to have a creatine clearance \< 15. * metastatic neoplasm * patients who received iv mgso4 in the last week. * hypotension, defined as systolic blood pressure less than 90.

Keywords: copd aecopd magnesium sulfate acute exacerbation of copd chronic obstructive pulmonary disease ed er emergency department
effectiveness of diclofenac and its association to codeine after lower third molar extraction.

Conditions: Impacted Third Molar Tooth

Summary: it will be evaluated the clinical efficacy of diclofenac 50mg (nsaid) compared to its association with codeine 50mg (opioid) administered in 50 patients requiring extraction of two third molars. after assessing the research parameters, a comparative data analysis, along with the proper application of statistical tests, will provide the basis for an evaluation of both efficiency medications used.

this research will evaluate the clinical efficacy of diclofenac 50mg (nsaid) compared to its association with codeine 50mg (opioid) administered in 50 patients aged less than 18 and requiring extraction of two third molars (with very similar positions, whose degree of difficulty is high). it will be assessed the following parameters: 1) onset and duration of surgery after administration of local anesthetic, 2) open mouth prior to surgery, on the 2nd day after the operation and on the 7th day after surgery (removal points), 3) subjective assessment of pain using a visual analog scale, 4) measurement of facial edema in the second day after the operation and on the 7th day after surgery (as compared with the measurements obtained before surgery) and 5) the incidence, type and severity of adverse reactions. the analysis comparative data, along with the proper application of statistical tests, provide the basis for an evaluation of both efficiency medications used.

Eligibility criteria:
inclusion criteria: * impacted lower third molar * not in use of nsaid or opioids in the last one month exclusion criteria: * local anesthetics allergy, * history of gastrointestinal bleeding or ulcers, * kidney disease, * asthma, * allergy or sensitivity to aspirin or any other nsaid or opioids, * pregnant or nursing woman, * patients using antidepressant, diuretic or aspirin, * patients under treatment to quit drugs

Keywords: codeine diclofenac impacted third molar tooth
thermage cpt for treatment of facial and neck laxity

Conditions: Skin Aging

Summary: the purpose of this study to evaluate treatment with the thermage cpt system for facial and neck laxity.


Eligibility criteria:
inclusion criteria: * 25 - 65 years of age * moderate facial and neck laxity * subject has the ability to follow the study instructions, is willing to be available on the specific required study visit days, and is willing to complete all study visit procedures and assessments. * subject must understand the research nature of this study and sign an institutional review board (irb)-approved informed consent prior to the performance of any study specific procedure or assessment. * subject agrees not to undergo excluded procedures on the face and neck for the duration of study. exclusion criteria: * subject is pregnant or breast feeding, or trying to become pregnant for three months prior to or during the study. * pacemaker, internal defibrillator, or other implanted electronic device * subject has an active localized infection in the treatment area(s) or an uncontrolled systemic infection. * subject has had prior cosmetic procedures on the treatment area(s) within six months of the baseline visit.
genetics study of in-stent restenosis

Conditions: Coronary Artery Disease

Summary: the investigators hypothesized that genetic variants of g protein influence the development of restenosis and clinical outcome of patients receiving drug-eluting stents (des).

although drug-eluting stents (des) have reduced restenosis rates compared with bare-metal stents, the restenosis rate is still high in the high-risk group. g protein plays important roles in the signal transduction leading to vascular smooth muscle proliferation. the initial and subsequent studies suggest that the t allele of c825t polymorphism is associated with enhanced transmembrane signaling via gi proteins.

Eligibility criteria:
inclusion criteria: * patients who underwent follow-up angiography. all the patients must had been implanted with des during the last two years. exclusion criteria: * for the non-isr group, the patients underwent follow-up angiography less than 6 months away from stent implanting.

Keywords: coronary stent implant polymorphism g protein drug-eluting stent restenosis
effectiveness and safety of semaglutide combined with dietary fiber (soloways) in adults with overweight or obesity

Conditions: Overweight and Obesity

Summary: this clinical trial investigated the combined effects of semaglutide and a fiber supplement (glucomannan, inulin, psyllium) on weight loss in adults with overweight or obesity. participants, aged 18-65 with a bmi ≥30 or ≥27 with comorbidities, were randomized into two groups: one receiving semaglutide with active fiber supplements and the other with semaglutide and placebo, over a 180-day period. key endpoints included percentage change in body weight, bmi, body composition, safety, and appetite control, with a focus on evaluating the additive effects of dietary fibers in enhancing semaglutide's efficacy.


Eligibility criteria:
inclusion criteria: * bmi ≥30, or ≥27 with comorbidities. exclusion criteria: * serious chronic illnesses. * history of bulimia or anorexia. * pregnancy or lactation.

Keywords: semaglutide weight loss obesity appetite suppression